Active Pharmaceutical Ingredients Production

Ranbaxy Laboratories Limited was an Indian pharma company that was launched in 1937 by two cousin brothers.

Ranbir Singh and Gurbax Singh, were the founders of the company from which the company’s name was derived, “Ran” from “Ranbir” and “Bax” from “Gurbax”, thus the name, “Ranbaxy”.

For starters, the brothers worked for distributing the Japanese pharma giant Shinogi’s drugs in India. The company was bought from the brothers by their own cousin, Mohan Singh in 1952.

Primarily, Ranbaxy Laboratories Limited was incorporated in 1961 and when Mohan’s son Parvinder joined in 1967, the company quickly saw expansion at a large scale.

In 1998, Ranbaxy finally entered the world’s largest pharmaceutical market, the United States of America. This led to a significant increase in Ranbaxy’s market. In 2005, 28% of the company’s sales came from the market of United States.

While Ranbaxy was later acquired by Daiichi Sankyo, a Japanese pharmaceutical company, and even later by its own Indian rival, Sun Pharmaceutical, it all happened due to negligence and severe shortcomings of Ranbaxy itself.

The negligence and whistleblowing

Dinesh Thakur and Rajinder Kumar blew the whistle in 2004-2005 when they realized that the company was involved in the fabrication of the screening results of their drugs.

In 2005, Rajinder was forced to resign out of Ranbaxy when he was accused by the company of accessing pornographic content on his office computer.

This finally led Dinesh in a search for justice, on a path that finally led to the end of Ranbaxy. Thakur left for the United States where he met with the FDA and informed them about the fabrication of the tests.

On over 15 brand new generic drugs, 1600 data errors came to light, when the FDA investigated, and they found that the company had gotten into the habit of filing false claims. The biggest issue with this discovery was the realization that due to these false claims, the drugs were illegal to sell.

Generic drugs and bioequivalence

Generic drugs are made once the rights of the original manufacturer of the drug, expire. When this happens, pharmaceutical companies start manufacturing and selling generic drugs which are biologically equivalent to the branded drugs. Ranbaxy was also a generic drug manufacturing company, and while working there, Thakur found out that the bioequivalence data for many of these alternate generic drugs didn’t even exist. More disturbing was the fact that at times, the bioequivalence data was fabricated as required, to pass the screening tests.

Vince Fabiano, the former president of Ranbaxy said that Ranbaxy used fraud for gaining a competitive edge over its rivals, in the USA.

He also gave an example of a cancer patient. If a cancer patient is given a drug like the one manufactured by Ranbaxy (with false records), if the cancer increases/decreases, there won’t be any way to know if the drug caused it. On top of it, if the cancer does increase, then ultimately, it’s the patient who’ll be harmed.

More controversies

On 8 February 2012, Pantoprazole’s three batches were recalled, in Netherlands, as they considered impurities (which can have very severe effect on the patient).

On 9 November 2012, the company ended up recalling a very large number of the drug, atorvastatin as in some of its bottles, glass particles were found.

In 2014, atorvastatin’s bottles were again recalled as on the bottles which were labeled as to be containing 10mg tablets, 20mg tablets were found.

In 2013, the company finally pleaded guilty to the felony charges which included the manufacturing and distribution of adulterated drugs, and for filing false generic drug data (bioequivalence data). Ranbaxy pleaded guilty to 3 felony FDCA counts and four felony counts.

Despicable is the fact that among the adulterated drugs, were drugs which were to be sent to Africa for the treatment of HIV/AIDS.

Acquisition by Sun Pharma

On 7 April 2014, Daiichi Sankyo, which held a marginal 63.4% share in Ranbaxy, announced that it had sold its entire share to Sun Pharma in a $4 billion deal.

This led to the creation of India’s largest pharma company.

Conclusion

Many of the things that Ranbaxy did in an attempt to expand themselves, ultimately put the lives of the patients at stake, which is, as we have noted before, extremely despicable. As a responsible active pharmaceutical ingredient manufacturer, they should have been more responsible and ethical before attempting to use fraud to gain advantage over their rivals.

All in all, it is only due to the responsible citizens like Thakur, and organizations like FDA which responsibly attend to their duty of making our dependency on pharmaceutical drugs, safer. In our upcoming articles, we’ll talk more about other pharmaceutical companies and evolution of pharmacy, along with shedding light on some drugs.